FDA 510(k) Application Details - K241479

Device Classification Name	More FDA Info for this Device
510(K) Number	K241479
Device Name	Etiometry Platform (DAV 5.4 RAE 9.2)
Applicant	Etiometry Inc. 280 Summer St. Fourth Floor Boston, MA 02210 US Other 510(k) Applications for this Company
Contact	Tim Hanson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2024
Decision Date	02/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review